Effect of Polysaccharide-based Complex Administration on the Gut Microbiome and Cardio-Metabolic Profile in Children With Obesity and Metabolic Syndrome.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2024-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Childhood obesity is a growing public health concern and is associated with long-term health issues. Changing lifestyle habits, especially improving diet and maintaining these changes over time, can be challenging for children and families. For this reason, new treatment options are being explored, including ways to improve the gut microbiota, which can influence appetite and host metabolic health.

This study will investigate the impact of a medical device made of polysaccharide-based complex together with healthy lifestyle and dietary intervention, on gut microbiota composition and metabolic health in children and adolescents with metabolically unhealthy obesity. The study will last 8 months and will include 3 visits: at the start (T0), after 4 months (T1), and after 8 months (T2). From T0 to T1, participants will receive the polysaccharide-based complex along with Mediterranean-style dietary and behavioral intervention. From T1 to T2, only the dietary-lifestyle program will continue.

At each visit, researchers will collect blood samples, perform nutritional and body composition assessment, and collect stool samples to characterise the gut microbiota. The primary aim is to evaluate the effect on gut microbiota composition of a polysaccharide-based complex administration combined with dietary and lifestyle interventions. Furthermore, the study aims to evaluate the effectiveness of this intervention in improving obesity-related parameters and the overall cardiometabolic profile.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Lifestyle Interventions and Metabolic Profile in Obese Children

NCT03728621

Childhood Obesity Obesity Pediatric Obesity +3 more

COMPLETED NA

MuLtidimensional School-based and Family interVentions to Promote hEalthy and Sustainable LifestYle for the Childhood

NCT05966051

Childhood Obesity

COMPLETED

Effect of Prebiotic Intake on Adiposity, Satiety and Gut Microbiota in Overweight and Obese Children

NCT02125955

Overweight Obesity

COMPLETED NA

Role of Carbohydrate Modification in Weight Management Among Obese Children

NCT00215111

Childhood Obesity

COMPLETED NA

Childhood Obesity Microbiome Study

NCT04770311

Pediatric Obesity

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Childhood Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single-arm Pre-Post Treatment

At T0 (enrollment), participants will undergo baseline assessments. From T0 to T1, they will receive a polysaccharide-based complex together with a dietary and lifestyle intervention based on Mediterranean diet principles. From T1 to T2, the polysaccharide-based complex will be discontinued, and participants will continue only with the dietary and lifestyle intervention as a washout phase. Assessments at T0, T1, and T2 will be used to evaluate changes over time.

Group Type EXPERIMENTAL

Polysaccharide-based complex

Intervention Type DEVICE

The Polysaccharide-based complex is a medical device composed of mixture of soluble and insoluble fibres (cellulose, hemicellulose, pectin, mucilages). After enrolment at T0, participants were instructed to consume a polysaccharide-based complex for 4 months at a dosage of two sachets daily, to be consumed one before lunch and one before dinner (total 5 g/day).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Polysaccharide-based complex

The Polysaccharide-based complex is a medical device composed of mixture of soluble and insoluble fibres (cellulose, hemicellulose, pectin, mucilages). After enrolment at T0, participants were instructed to consume a polysaccharide-based complex for 4 months at a dosage of two sachets daily, to be consumed one before lunch and one before dinner (total 5 g/day).

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Neo-Policaptil Gel Retard

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age 8 to 14 years;
* obesity defined as BMI z-score ≥+2 standard deviation scores (SDS) based on the WHO growth charts
* gestational age 37-42 weeks;
* birth weight \>2500 g and \<4000 g;
* established condition of MUO, defined as follows:

1. for children ≤10 years according to the IDEFICS criteria \[waist circumference (WC) ≥90th percentile and ≥1 of the followings triglycerides (TG) ≥90th percentile, HDL cholesterol (HDL) ≤10th percentile, systolic blood pressure (SBP) or diastolic blood pressure (DBP) ≥90th percentile, HOMA-insulin resistance ≥90th percentile or fasting glucose ≥90th percentile\];
2. for children \>10 years according to the IDF criteria \[WC ≥ 90th percentile and ≥1 of the followings TG ≥ 150 mg/Dl, HDL ≤ 40 mg/dL, SBP ≥ 130 mmHg, DBP ≥ 85 mmHg and fasting blood glucose ≥ 100 mg/dl or known Type 2 Diabetes\]

Exclusion Criteria

* diagnosis of secondary obesity;
* treatment with pre/probiotics in the previous 3 months;
* antibiotic treatment in the previous 3 months;
* presence of chronic or acute intestinal disease in the previous 3 months

Minimum Eligible Age

8 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No